EP2714169B1 - Deckblech - Google Patents

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Publication number
EP2714169B1
EP2714169B1 EP12726079.2A EP12726079A EP2714169B1 EP 2714169 B1 EP2714169 B1 EP 2714169B1 EP 12726079 A EP12726079 A EP 12726079A EP 2714169 B1 EP2714169 B1 EP 2714169B1
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EP
European Patent Office
Prior art keywords
covering sheet
medial
central
elements
tracheostoma
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12726079.2A
Other languages
English (en)
French (fr)
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EP2714169A1 (de
Inventor
Jan-Ove Persson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Atos Medical AB
Original Assignee
Atos Medical AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Atos Medical AB filed Critical Atos Medical AB
Priority to EP19159458.9A priority Critical patent/EP3552589A1/de
Priority to PL16163689T priority patent/PL3061484T3/pl
Priority to EP16163689.9A priority patent/EP3061484B1/de
Priority to PL12726079T priority patent/PL2714169T3/pl
Publication of EP2714169A1 publication Critical patent/EP2714169A1/de
Application granted granted Critical
Publication of EP2714169B1 publication Critical patent/EP2714169B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/047—Masks, filters, surgical pads, devices for absorbing secretions, specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0269—Tapes for dressing attachment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1045—Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A61M16/0688—Holding devices therefor by means of an adhesive
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/14—Layer or component removable to expose adhesive

Definitions

  • This invention pertains in general to a covering sheet for covering a skin adhesive surface of devices for holding a trachestoma device and a method for applying such a device. More particular the invention pertains to a multi parted covering sheet, for such application.
  • a tracheostomy is a surgical procedure in which an opening is formed through the anterior surface of the neck into the trachea.
  • the opening is referred to as a tracheostoma.
  • a tracheostomy tube can be provided to extend between the tracheostoma and the trachea.
  • a tracheostomy is performed for example when there is a malfunction, such as a result from injury or disorder, in respect of the nervous system or the respiratory passages, which malfunction results in an incapacity to obtain enough air.
  • An inferior lung capacity or need of respiratory treatment may also result in a tracheostomy.
  • a laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and the creation of a tracheostoma.
  • a consequence of the procedure is that the trachea is no longer connected to the pharynx but is diverted to the tracheostoma.
  • normal nasal function is not possible.
  • the nose and the mucous membrane lining of the nasal cavity perform important functions in conditioning inhaled air.
  • the convoluted passages and rich blood supply serve to increase both the temperature and humidity of the inhaled air to minimise the differential in these parameters with those of the surface of the lungs. Normally some heat and moisture is also captured from exhaled air prior to its release to the atmosphere.
  • the mucous lining of the nasal passages also serves to remove particulate matter, such as fine dust particles, pollutants and microorganisms, from the inhaled air, and the action of cilia transports mucous and any particles away from the lungs.
  • inhaled air When a patient has received a laryngectomy, in effect all inhaled air enters the lungs via the tracheostoma, and the nose is effectively not involved in the inhalation process. Exhaled air may pass through the tracheostoma or, if a voice prosthesis has been fitted, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis into the pharynx and the mouth, enabling the patient to speak. It is desirable that the flow of the exhaled air be controlled by means of a tracheostoma valve. In these situations, the valve can be arranged to remain open during breathing but, with a small additional increase in exhaled air flow, can be closed to divert the airflow.
  • tracheostoma devices such as filter devices, HME, breathing protectors, and speech valves, have been developed to enable moisturizing of inhaled air, removal of small particles and bacteriological substances in said inhaled air, and providing the patient with the ability to speech by closing the air passage through the trachestoma by manual operation.
  • tracheostoma devices are held in place by a tracheostoma device holder, arranged above the tracheostoma of the patient.
  • the tracheostoma device holder is attached to the skin of the patient by a plaster, having an adhesive surface on the side of the plaster intended to be directed towards the patient in use.
  • the tracheostoma device holder is welded to the plaster, or the tracheostoma device holder is on an adhesive surface on the side of the plaster intended to be directed outwards from the patient in use.
  • a covering sheet may be applied, which is removed just before application of the tracheostoma device holder. The covering sheet facilitates transportation, and maintains skin adhesive ability of the skin adhesive surface.
  • the surgical steps during laryngectomy are adapted for creating stomas of substantially planar natures, to comply with the tracheostoma device holder system presently on the market.
  • This adaptation includes the cutting of the two vertical sternocleidomastoid muscles on the neck.
  • WO 2010/070087 discloses a multi parted covering sheet, which may be removed from the skin adhesive surface of the tracheostoma device holder in sequence, such that parts of the skin adhesive surface of the tracheostoma device holder are revealed and attached to the skin in sequence.
  • the covering sheet arrangement herein is however unnecessarily thick, due to folded lateral covering sheets. Also, due the folded lateral covering sheets, there tends to be a string of uncovered skin adhesive surface in between the lateral covering sheet elements and the central covering sheet, since the central covering sheet continues over the lateral covering sheet elements.
  • an improved covering sheet arrangement for a tracheostoma device holder would be advantageous, and in particular a covering sheet arrangement allowing for convenient application of the system with improved positioning ability, maintained skin adhesive property over the entire skin adhesive surface of the tracheostoma device holder, and decreased thickness of the covering sheet arrangement, etc
  • Document US 5,088,483 discloses an adhesive composite comprising a backing layer having a central element and two lateral elements, wherein division lines are provided between the central element and either of the lateral elements.
  • the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a covering sheet for covering the skin adhesive surface of a device for holding a trachestoma device over a tracheostoma of a patient, said covering sheet comprising: a central/medial element for covering the central/medial part of the skin adhesive surface of a device; first and second elements being arranged laterally of the central/medial element, wherein the peripheral border of the central/medial element is positioned adjacent medial peripheral borders of the first and second elements, said peripheral borders being defined by division lines; a device for holding a tracheostoma device, comprising a passage, giving the device a distal and a proximal opening, for receiving the tracheostoma device in/at the distal opening thereof; a flange, extending laterally, caudially, and cranially from the through
  • the following description focuses on an embodiment of the present invention applicable to a covering sheet for application on the skin adhesive surface of a system for holding a tracheostoma device over a tracheostoma of a patient.
  • a system for holding a tracheostoma device over a tracheostoma of a patient i.e. a tracheostoma device holder, 100 is disclosed.
  • a corresponding backside view is disclosed in Fig. 2 .
  • a tracheostoma device may in this context be a HME, speech valve, etc.
  • the device comprises a tubular portion for receiving the tracheostoma device in the distal end thereof.
  • the tubular portion may be of a circular cross-section, in a plane perpendicular to the central axis of the tubular portion.
  • a flange 102 is provided, around the proximal opening of the tubular portion 101.
  • the flange 102 comprises an inner rigid portion 103 and an outer more flexible portion 104.
  • the flange 102 extends radially outwards from a proximal part of the tubular portion 101, in a plane perpendicular to the central axis of the tubular portion 101, said plane being the dorsal plane in use.
  • the flange 102 has a proximal side, intended to face the tracheostoma of the patient, and a distal side, intended to face outwardly from the patient.
  • the flange 102 is inclined, distally towards the central axis of the tubular portion 101, at least in the inner rigid portion 103.
  • the entire rigid portion 103 is inclined distally towards the central axis of the tubular portion 101, whereby improved contact with sunken stomas may be achieved.
  • the distal side of the flange 102 is provided with reinforcement.
  • the reinforcement extends centrally in the caudal/cranial direction, giving a higher moment of resistance in the caudal/cranial direction than in the lateral/medial direction for the device 100.
  • the higher moment of resistance in the caudal/cranial direction may be obtained by having a higher moment of resistance in the caudal/cranial direction than in the lateral/medial direction for at least a part of said flange 102.
  • the reinforcement will absorb the speech pressure and transfer the obtained force centrally in the caudal/cranial direction.
  • the reinforcement may be a bracing means 105.
  • bracing means 105 could be localized on the proximal side of the flange 102, it is preferred to have the bracings 105 on the distal side, since such location would make possible a smooth and even contact surface between the device 100 and the skin of the patient. Also, it is convenient to have the bracings 105 on the distal side, since the inclination of the flange 102 allows for a concavely shaped distal side, whereby the bracings 105 may be placed confidently low, i.e. sufficiently far to the proximal end, to make possible a satisfactory stiffness, while simultaneously not being prone to interaction with clothing etc.
  • the bracing means 105 are preferably ribs extending in a plane perpendicular to the central axis of the tubular portion 101, thus being the dorsal plane in use. In this connection the ribs extend in the caudal/cranial direction. However, the bracing means 105 may also be a higher material thickness in the caudal/cranial direction than in the lateral/medial direction.
  • two ribs extend substantially tangentially with the circular tubular portion 101 and parallel with each other, such that they in use extend along the caudal/cranial extension of the neck of the patient.
  • the device 100 may have a heterogeneous plasticity, whereby the device 100 has a higher deformation resistance in the direction parallel with the extension of the bracing means 105, i.e. the caudal/cranial direction, than in the direction perpendicular to the extension of the bracing means 105, i.e. the medial direction.
  • the flange 102 of the device 100 may be compressed medially, i.e.
  • the device may come in good skin contact also on sunken stomas.
  • the device is provided with two weakening lines, to further increase the difference in moment of resistance between the caudal/cranial direction and the lateral/medial direction for said device 100.
  • the weakening lines give rise to reinforcement in the caudal/cranial direction.
  • the proximal side of the flange 102 is skin-adhesive. In one embodiment only parts of the proximal side is skin-adhesive.
  • the skin-adhesive part may extend all the way from the periphery of the device to the tubular portion 101.
  • the skin adhesive part may be the proximal side of a flexible sheet onto which the more rigid inner part 103 is welded.
  • the outer part of the flexible sheet, skin-adhesive on the proximal side will be the flexible part 104 of the flange 102.
  • the weld is located radially distanced from the tubular portion 101, such as at the periphery of the more rigid part 103. In this way, the skin-adhesive part may be adhered to the skin at higher stress conditions in the distal direction, since the weld will take up the stress on a distance away from the edge of the skin adhesive part.
  • the inner rigid portion 103 of the flange 102 is preferably oval, having its approximated longest diameter in the same direction as the extension direction of the bracing means 105, i.e. in the caudal/cranial direction of a caudal/cranial axis. Similarly, the approximated smallest diameter is in the lateral/medial direction of a lateral/medial axis.
  • the outer more flexible portion 104 may be substantially circular or oval with indentations, such that for example a flower shape is obtained. In this way it may be easier to adhere the outer parts of the flange to the skin of the patient, without the need of folding the flexible portion to compensate for irregularities in the shape of the neck of the patient. In this way the contact area between the device 100 and the skin of the patient may be kept sufficiently high, within the two sternocleidomastoid muscles, to allow for safe attachment of the device to the skin of patients with sunken stomas.
  • a covering sheet 200 is arranged, for facilitating transportation, storing, and application of the device 100.
  • the covering sheet is illustrated from a front side view, thus arranged behind/proximally of the tracheostoma device holder.
  • the covering sheet is of a suitable polymer, such as a thermoplastic polymer. Suitable thermoplastic polymers are polyethylene and polypropylene. In one embodiment the covering sheet 200 is made of polypropylene.
  • the covering sheet 200 surrounds the proximal opening of the device 100.
  • the covering sheet 200 comprises a central/medial element 201, and a first and a second side element 202, 203, arranged laterally of the central element 201.
  • the first and the second side elements 202, 203 are applied from the tubular element 102 laterally on each side of the tubular element 102, respectively, covering side segments of the adhesive surface of the device 100.
  • the central/medial segment of the adhesive surface of the device 100 will still be uncovered by the first and the second side elements 202, 203, once the central/medial element 201 has been removed from the skin adhesive surface of the device 100.
  • the central/medial segment of the adhesive surface of the device 100 will be the surface that in use will extend upwards and downwards from the tubular element 102 in a caudal/cranial direction, said central/medial segment being adapted in size and form to fit within the two sternocleidomastoid muscles.
  • the central/medial element 201 and the first and second side elements may each be provided with a tab, 204, 205, 206, respectively, to facilitate removal of the elements.
  • the tabs 204, 205, 206 may extend outside the periphery of the skin adhesive surface of the device 100, to further facilitate removal of the elements 201, 202, 203, respectively.
  • the central/medial element 201 and the first and second elements 202, 203 are arranged in one layer/sheet, such that the lateral peripheral border of the central/medial element 201 is arranged adjacent and in close contact with the medial peripheral border of the first and second elements 202, 203.
  • the central/medial element 201 forms the periphery of the covering sheet 200, at least partly.
  • the periphery of the central/medial element 201 forms the periphery of the covering sheet 200 at the central/medial part at the cranial end and/or the caudial end.
  • the first and second elements 202, 203 are entirely separated by the central/medial element 201, such that they not are in close contact. In this way a vertical division of the covering sheet 200 into a medial/central element 201, a first lateral element 202, and a second lateral element 203 has been obtained. It is preferred to keep the distance between the central/medial element 201 and the first and second elements 202, 203 as small as possible. This may be accomplished by razor blade cutting division lines 207, 208, to divide the covering sheet 200 into said central/medial element 201 and said first and second elements 202, 203.
  • the covering sheet 200 is made of a mono-oriented thermoplastic polymer, such as a mono-oriented polypropylene (MOPP).
  • MOPP mono-oriented polypropylene
  • Mono-oriented polymer means that the polymer material has polymer molecules substantially oriented in one direction. The orientation of the mono-oriented polymer may then coincide with the caudal/cranial direction of the intended use, such that the division lines 207, 208 substantially coincide with the direction of the mono-orientation of the mono-oriented polymer.
  • a cut such as a cut by razor blade or razor blade cutter, there is no need to cut entirely through the covering sheet, while still obtaining satisfactory separation of the elements when removing for example the medial/central element 201.
  • division lines 207, 208 are in the form of trenches in the covering sheet 200, i.e. wherein also the bottom of the cuts of the division lines are comprised in the covering sheet 200.
  • the first and second elements 202, 203 may remain in place after the removal of said central/medial element 201, without entirely separating the elements through cutting. The pulling of the element to be removed will initiate full rupture of the division lines, without being accompanied by the other elements. Also, a too deep cut of the covering sheet 200 when forming the division lines will decrease the strength of the covering sheet 200.
  • division lines 207, 208 are perforation lines.
  • the division lines 207, 208 in form of perforation lines or trenches may comprise an edge cut extending entirely through the covering sheet 200, to facilitate initialization of division along said division lines 207, 208.
  • Such edge cut may then have an extension of 1 mm to 10 mm, such as 2 to 7 mm.
  • the covering sheet 200 is heat shaped together with the device 100, to obtain the three-dimensional convex shape at the proximal surface of the device 100.
  • a polymer with low melting point such as polyethylene or polypropylene, preferably covered by a silicone coating for improved separation between the adhesive surface and the covering sheet.
  • a user or applier may (i) position the device 100 over the stoma of the patient, after the central/medial covering element 201 of the covering sheet 200 has been removed, by holding on the first and second elements 202, 203; squeezing the device 100 in the medially direction, without deforming the tubular part 102 too much, due to the bracing means 105, and safely apply the device with good skin contact, even on sunken stomas, due to the convexly shaped proximal side of the flange 102, whereby the application of the device 100 is facilitated by only having the central/medial segment of the device 100 skin-adhesive during application; thereafter (ii) pull the tabs 205, 206 laterally and thus removing the first and second elements 202, 203 and uncovering, in a lateral direction, the skin-adhesive parts there beneath, until the first and second elements 202, 203 have been removed and detached from the device 100, whereby the entire skin adhesive prox

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Claims (13)

  1. Abdeckfolie (200) zum Abdecken der Hautadhäsivfläche einer Vorrichtung (100) zum Halten einer Tracheostoma-Vorrichtung über einem Tracheostoma eines Patienten, wobei die Abdeckfolie (200) umfasst:
    ein zentral/mediales Element (201) zum Abdecken des zentral/medialen Teils der Hautadhäsivfläche einer Vorrichtung (100);
    erste und zweite Elemente (202, 203), die seitlich von dem zentralen/medialen Element (201) angeordnet sind, wobei
    ein peripherer Rand des zentralen/medialen Elements (201) benachbart zu medialen peripheren Rändern des ersten und zweiten Elements (202, 203) angeordnet ist, wobei die peripheren Ränder durch Teilungslinien (207, 208) definiert sind, dadurch gekennzeichnet, dass
    die Abdeckfolie aus einem monoorientierten Polymer hergestellt ist, wobei die Richtung der Teilungslinien (207, 208) zumindest teilweise mit der Ausrichtung des monoorientiertes Polymers übereinstimmt.
  2. Abdeckfolie nach Anspruch 1, wobei das zentrale/mediale Element (201) mit einem Durchgangsloch zur Übereinstimmung mit einer proximalen Öffnung der Vorrichtung (100) versehen ist.
  3. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei das zentrale/mediale Element (201) und das erste und zweite Element (202, 203) in einer Schicht/Folie angeordnet sind.
  4. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei der laterale periphere Rand des zentralen/medialen Elements (201) angrenzend und in engem Kontakt mit dem medialen peripheren Rand des ersten und zweiten Elements (202, 203) angeordnet ist.
  5. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei die Peripherie des zentralen/medialen Elements (201) die Peripherie der Abdeckfolie am zentralen/medialen Teil am kranialen Ende und am kaudalen Ende bildet.
  6. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei die Teilungslinien (207, 208) das zentrale/mediale Element (201) von dem ersten und zweite Elemente (202, 203) trennen.
  7. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei die Teilungslinien (207, 208) nur teilweise in die Abdeckfolie eindringen.
  8. Abdeckfolie nach einem der Ansprüche 1 bis 5, wobei die Teilungslinien (207, 208) Perforationslinien sind.
  9. Abdeckfolie nach einem der vorstehenden Ansprüche, wobei die Abdeckfolie aus einem thermoplastischen Polymer hergestellt ist.
  10. Vorrichtung (100) zum Halten einer Tracheostoma-Vorrichtung, umfassend:
    einen Durchgang (101), der der Vorrichtung (100) eine distale und eine proximale Öffnung gibt, zum Empfangen der Tracheostoma-Vorrichtung in/an der distalen Öffnung derselben;
    einen Flansch (102), der sich seitlich, kaudal und kranial von der Durchgangsöffnung erstreckt, wobei der Flansch (102) eine proximale Seite aufweist, die dazu bestimmt ist, dem Tracheostoma des Patienten zugewandt zu sein und eine distale Seite, die dazu bestimmt ist, vom Patienten nach außen zu zeigen, wobei
    mindestens ein Teil der proximalen Seite hautadhäsiv ist, wobei
    eine Abdeckfolie (200) nach einem der Ansprüche 1 bis 9 auf der proximalen Seite angeordnet ist.
  11. Vorrichtung nach Anspruch 10, wobei die Vorrichtung (100) eine Vorrichtung zum Halten eines HME oder Sprachventils ist.
  12. Vorrichtung nach Anspruch 10 oder 11, wobei die proximale Seite ein konvex geformtes Teil aufweist.
  13. Verfahren zum Anbringen einer Vorrichtung nach einem der Ansprüche 10 bis 12 über einem Stoma eines Patienten, umfassend die Schritte von:
    Entfernen mindestens des medialen/zentralen Elements (201);
    Positionieren der Vorrichtung über dem Stoma des Patienten;
    Anbringen der hautadhäsiven proximalen Seite des Flansches (102) der Vorrichtung an der Haut des Halses, die von mindestens dem medialen/zentralen Element (201) bedeckt ist;
    Entfernen des ersten und zweiten Elements (202, 203); und
    Anbringen der hautadhäsiven proximalen Seite des Flansches (102) der Vorrichtung an der Haut des Halses, die durch das erste und zweite Element (202, 203) abgedeckt ist.
EP12726079.2A 2011-05-31 2012-05-31 Deckblech Active EP2714169B1 (de)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP19159458.9A EP3552589A1 (de) 2011-05-31 2012-05-31 Decklage
PL16163689T PL3061484T3 (pl) 2011-05-31 2012-05-31 Arkusz okrywający
EP16163689.9A EP3061484B1 (de) 2011-05-31 2012-05-31 Deckblech
PL12726079T PL2714169T3 (pl) 2011-05-31 2012-05-31 Arkusz okrywający

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE1150506 2011-05-31
PCT/EP2012/060199 WO2012163994A1 (en) 2011-05-31 2012-05-31 Covering sheet

Related Child Applications (3)

Application Number Title Priority Date Filing Date
EP19159458.9A Division EP3552589A1 (de) 2011-05-31 2012-05-31 Decklage
EP16163689.9A Division EP3061484B1 (de) 2011-05-31 2012-05-31 Deckblech
EP16163689.9A Division-Into EP3061484B1 (de) 2011-05-31 2012-05-31 Deckblech

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EP2714169B1 true EP2714169B1 (de) 2019-02-27

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EP12726079.2A Active EP2714169B1 (de) 2011-05-31 2012-05-31 Deckblech
EP16163689.9A Active EP3061484B1 (de) 2011-05-31 2012-05-31 Deckblech
EP19159458.9A Withdrawn EP3552589A1 (de) 2011-05-31 2012-05-31 Decklage

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US (1) US10052447B2 (de)
EP (3) EP2714169B1 (de)
JP (1) JP6381440B2 (de)
CN (1) CN103582506B (de)
DE (1) DE202012013326U1 (de)
ES (2) ES2656393T3 (de)
PL (2) PL2714169T3 (de)
WO (1) WO2012163994A1 (de)

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USD847982S1 (en) * 2016-02-04 2019-05-07 Atos Medical Ab Heat exchanger base plate
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USD832427S1 (en) * 2016-02-04 2018-10-30 Atos Medical Ab Heat and moisture exchanger base plate
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DE202020004707U1 (de) * 2020-11-10 2021-04-22 Sven Gränert Tracheostomaabdichtung von Leckagen zur Phonation bei tracheotomierten, beatmeten Patienten

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Also Published As

Publication number Publication date
CN103582506B (zh) 2016-01-13
DE202012013326U1 (de) 2016-04-25
US10052447B2 (en) 2018-08-21
ES2656393T3 (es) 2018-02-27
JP6381440B2 (ja) 2018-08-29
PL3061484T3 (pl) 2018-05-30
CN103582506A (zh) 2014-02-12
JP2014516720A (ja) 2014-07-17
PL2714169T3 (pl) 2019-08-30
EP3552589A1 (de) 2019-10-16
EP3061484B1 (de) 2017-11-15
EP3061484A1 (de) 2016-08-31
ES2723789T3 (es) 2019-09-02
US20140216445A1 (en) 2014-08-07
EP2714169A1 (de) 2014-04-09
WO2012163994A1 (en) 2012-12-06

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